Agency classClass IIOur severity:High FDA (Devices)·Z-2091-2017·Announced 2017-05-24

Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error

Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for emergency ventilatory support where a functional defect prevents the device from operating as intended. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Vortran Medical Technology 1, Inc. is recalling 35 cases of the VORTRAN Automatic Resuscitator, VARPlus, Model PTE-5002. The recall involves specific lots with expiry dates ranging from April 24, 2019, to June 30, 2019. The affected devices were distributed to locations in California, Mississippi, and Florida.

The recall was initiated after Vortran received a customer complaint stating that the spin-nut-DSS connector on the oxygen tubing was assembled in the reverse direction. This assembly error results in the wrong thread direction, making the connector unable to be screwed on. The device is intended to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure cycled ventilatory support.

Consumers and healthcare facilities should stop using the affected devices and contact Vortran Medical Technology 1, Inc. for further instructions or a replacement.

The recalled product

Product: VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Manufacturer: Vortran Medical Technology 1, Inc
Category: Medical Device — Respiratory / Ventilatory Support
Hazard: assembly-error
functional-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Model PTE 5002
Lot number/ expiry date: 1424 PTE
2019-04-24
1428 PTE
2019-05-06
1436 PTE
2019-06-16
1440 PTE
2019-06-30

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Vortran Medical Technology 1, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Vortran Medical Technology 1, Inc

See all →

High
Vortran Automatic Resuscitator Recalled Due to Reverse-Threaded Oxygen Connector
FDA (Devices) · 2017-05-24

Same hazard · assembly error